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Eisai's Dacogen five-day dosing regimen for treatment of MDS receives FDA approval

Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a five-day dosing regimen for Dacogen® (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.

12 Mar 2010

Bayer HealthCare Pharmaceuticals' ciprofloxacin DPI granted FDA orphan drug designation for CF treatment

Bayer HealthCare Pharmaceuticals announced today that an orphan drug designation has been granted by the U.S. Food and Drug Administration for ciprofloxacin dry powder inhaler for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients. A similar designation has already been granted by the European Medicines Agency.

12 Mar 2010

PhRMA spends $6.3 million lobbying in fourth quarter, slight increase from year before

The Pharmaceutical Research and Manufacturers of America spent $6.3 million lobbying Congress and other government arms on health care in the fourth quarter of 2009, The Associated Press reports. PhRMA "spent just 2 percent more than the $6.17 million it paid out for lobbying in the year-ago period.

12 Mar 2010

WHO welcomes Gates Foundation support in advancing global vaccine efforts

WHO welcomes the Bill & Melinda Gates Foundation pledge of US$ 10 billion over the next ten years to accelerate global vaccine efforts.

12 Mar 2010

HTDS receives Registration Certificate for MEVAC-Vari vaccine in Guatemala

Hard to Treat Diseases and its subsidiary Mellow Hope announce that the company received Registration Certificate for its MEVAC-Vari vaccine in Guatemala.

12 Mar 2010

Azur Pharma to acquire PRIALT analgesic therapy from Elan Pharmaceuticals

Azur Pharma Limited today announced it has signed a definitive agreement with Elan Pharmaceuticals, Inc. (a subsidiary of Elan Corporation, plc) to acquire the analgesic therapy, PRIALT(R) (ziconotide intrathecal infusion).

12 Mar 2010

Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

The U.S. Food and Drug Administration has accepted for review the supplemental new drug application (sNDA) of a new six-month 45-mg formulation of Lupron® Depot (leuprolide acetate for depot suspension) for use in the palliative treatment of advanced prostate cancer. Palliative treatment helps to relieve symptoms associated with advanced prostate cancer.

12 Mar 2010

Sigma-Aldrich announces global licensing agreement with CSIRO for RAFT agents

Sigma-Aldrich (Nasdaq: SIAL) announced today that it has entered into a worldwide licensing agreement with Australia's Commonwealth Scientific and Industrial Research Organization (CSIRO) to manufacture and sell Reversible Addition-Fragmentation chain Transfer (RAFT) agents – organic molecules that can be added to polymerization reactions to precisely control molecular weights and structures of polymers.

12 Mar 2010

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

Watson Pharmaceuticals, Inc., today announced the U.S. Food and Drug Administration approval of TRELSTAR® 22.5 mg (triptorelin pamoate for injectable suspension), a new twice-yearly formulation of TRELSTAR®, a proven, simple and effective palliative treatment of advanced prostate cancer.

11 Mar 2010

FDA warns healthcare professionals about bogus surgical mesh products

The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists.

11 Mar 2010

Advanced Life Sciences Holdings reports decrease in net loss for full-year 2009

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced its financial results for the fourth quarter and full year ended December 31, 2009.

11 Mar 2010

Legalising cannabis: School children debate

Should cannabis be legalised? This thorny political issue will be debated by teams of school children in a national competition designed to challenge the pupil's scientific knowledge. The event is part of the Festival of Social Science organised by the Economic and Social Research Council (ESRC) and will be staged at the Royal Pharmaceutical Society of Great Britain.

11 Mar 2010

Helix BioMedix enters into distribution agreement with RubyDerm Bio

Helix BioMedix, Inc., a developer of bioactive peptides, announced that the Company entered into an agreement with RubyDerm Bio, Inc. under which RubyDerm will assume responsibility, on an exclusive basis, for the distribution of certain of Helix BioMedix’s branded prestige skin care products to spas, beauty stores, hospitals, clinics, physicians, and consumers in South Korea, China and Japan.

11 Mar 2010

Evaluating true toxicity of drugs: Changes in collecting and reporting adverse symptom information needed

A Perspective piece in the New England Journal of Medicine calls for change in the way researchers and pharmaceutical companies collect and report adverse symptom information in clinical trials submitted to the Food and Drug Administration (FDA), and how the FDA represents this information on drug labels.

11 Mar 2010

Survey: Acute migraine therapy would earn 45% patient share in treatment of migraine

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that an acute migraine therapy that is not contraindicated in patients with a history, symptoms or signs of vascular disease and also offers improved efficacy and fast-acting oral delivery would earn a 45 percent patient share in the treatment of migraine, according to surveyed U.S. neurologists.

11 Mar 2010

iReminder’s white paper highlights key developments in HPV vaccine compliance and marketing efforts

Automated reminder and follow-up calls for HPV vaccinations increase adherence rates from 5% to over 20%, according to a new white paper published by iReminder, LLC. The Scotland National Health Service is the leader in HPV vaccination compliance, with rates as high as 92% for the first dose and 87.8% for the second dose. The laggard is Mississippi, USA where HPV vaccination rates are as low as 15.8%.

11 Mar 2010

Data from novel Hedgehog pathway inhibitor program to be presented at upcoming conferences

Infinity Pharmaceuticals, Inc., an innovative drug discovery and development company, today announced that members of its senior leadership and scientific teams will be leading discussions and presenting data from its novel Hedgehog pathway inhibitor program – an emerging area of cancer research – at several upcoming conferences.

11 Mar 2010

Study uncovers mechanism facilitating motivation for alcohol after extended abstinence

New research provides exciting insight into the molecular mechanisms associated with addiction and relapse. The study, published by Cell Press in the March 11 issue of the journal Neuron, uncovers a crucial mechanism that facilitates motivation for alcohol after extended abstinence and opens new avenues for potential therapeutic intervention.

11 Mar 2010

Non-smoked medical cannabis products needed, says National Drug Control Policy Deputy Director

Cannabis Science, Inc., a pioneering US pharmaceutical cannabis company, notes that comments by President Obama's Deputy Director of the White House Office of National Drug Control Policy, Tom McClellan, in yesterday's USA TODAY pinpoints the need for non-smoked medical cannabis products similar to those currently being developed for FDA clinical trials by Cannabis Science.

11 Mar 2010

Advitech receives product licence for psoriasis treatment product

Advitech Inc. ("Advitech" or the "Corporation") (TSX Venture Exchange: AVI) announces today that the Natural Health Products Directorate (NHPD) has issued to Advitech, on March 8, 2010, a Natural Product Number (NPN) for one of its main products, XP-828L/Dermylex.

11 Mar 2010

Pharmaceutical News

Eisai's Dacogen five-day dosing regimen for treatment of MDS receives FDA approval

Bayer HealthCare Pharmaceuticals' ciprofloxacin DPI granted FDA orphan drug designation for CF treatment

PhRMA spends $6.3 million lobbying in fourth quarter, slight increase from year before

WHO welcomes Gates Foundation support in advancing global vaccine efforts

HTDS receives Registration Certificate for MEVAC-Vari vaccine in Guatemala

Azur Pharma to acquire PRIALT analgesic therapy from Elan Pharmaceuticals

Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

Sigma-Aldrich announces global licensing agreement with CSIRO for RAFT agents

Watson Pharmaceuticals' TRELSTAR receives FDA approval for treatment of advanced prostate cancer

FDA warns healthcare professionals about bogus surgical mesh products

Advanced Life Sciences Holdings reports decrease in net loss for full-year 2009

Legalising cannabis: School children debate

Helix BioMedix enters into distribution agreement with RubyDerm Bio

Evaluating true toxicity of drugs: Changes in collecting and reporting adverse symptom information needed

Survey: Acute migraine therapy would earn 45% patient share in treatment of migraine

iReminder’s white paper highlights key developments in HPV vaccine compliance and marketing efforts

Data from novel Hedgehog pathway inhibitor program to be presented at upcoming conferences

Study uncovers mechanism facilitating motivation for alcohol after extended abstinence

Non-smoked medical cannabis products needed, says National Drug Control Policy Deputy Director

Advitech receives product licence for psoriasis treatment product

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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